Low and Negligible Risk Research Update - Ethics Andrew Thornton Chairman, HREC Royal Adelaide Hospital What is LNR Research? > The expression ‘low risk research’ describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk. > The expression ‘negligible risk research’ describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. NHMRC (2007) National Statement on Ethical Conduct in Human Research. Research that can be exempted from review > Institutions may choose to exempt from ethical review research that: (a) is negligible risk research; and (b) involves the use of existing collections of data or records that contain only non-identifiable data about human beings. > Quality Assurance activities > Audit activities NHMRC (2007) National Statement on Ethical Conduct in Human Research. Quality Assurance and Audit > An activity where the primary purpose is to monitor, evaluate or improve the quality of health care delivered is a quality assurance study. > Quality assurance and research are activities that form a continuum. The ethical principles of integrity, respect for persons, beneficence and justice apply to all QA and research activities. > Where quality assurance proposals could infringe ethical principles that guide human research, independent ethical scrutiny of such proposals should be sought. NHMRC (2003) When does quality assurance in health care require independent ethical review? Publishing and presenting QA or audit > Journal editors or conference organisers may have a view that any results presented require ethical oversight. > “Where it is proposed that a report of a QA activity undertaken in accordance with this advice is to be published, an HREC may advise a journal editor that it is satisfied that the activity has been so undertaken. This will obviate any need for requests for retrospective approval.” > When in doubt consult the committee. NHMRC (2003) When does quality assurance in health care require independent ethical review? What is LNR Research at RAH? > Non-invasive collection of specimens. > Collection of blood samples by venipuncture, in amounts not exceeding 450 millilitres in an eight week period and no more often than two times per week, from subjects who are 18 years of age or older and who are in good health and are not pregnant. > Moderate exercise by healthy volunteers. > The study of existing data, documents, records, pathological specimens, or diagnostic specimens. > Studies which involve exposure to ionising radiation of up to 1mSv in dose. What is NOT LNR Research > > > > > > > Research involving investigational drugs or investigational therapies (NS3.3). Research involving randomisation to one or more experimental treatments (NS3.3) Research involving genetic studies which may have relevance to a patient’s or relative’s current or future health (NS3.5). Research involving stem cells (NS3.6) Research which requires a third party consent or ICU research (NS4.4). Research in subjects with cognitive impairment or mental illness (NS4.5) Research involving aboriginal subjects (NS4.7) NHMRC (2007) National Statement on Ethical Conduct in Human Research. For LNR studies which may be suitable for expedited review > Check with Heather whether the study is appropriate for expedited review. Heather will consult the Chairman as necessary. > Submit electronically (eg email): • • • • • • • • Cover letter Protocol Informed Consent Questionnaires Advertising material Any other material Radiation Safety Report EPA Notification form SA Health LNR Application Form - Headings 1.1. 1.2. 1.3. 1.4. 2.1. 2.2. 2.3. 2.4. 2.5. 2.6. Project type Project title Project Short title Research Category Coordinating Principal Investigator Principal Investigator/s Associate Investigator/s Supervisor details Other personnel Nominated Contact for project SA Health LNR Application Form - Headings 3.1. Name/ID of HREC reviewing the project 3.2. Site/s involved in this project for which ethical and scientific approval is being sought from this HREC 3.3. Previous ethical review 3.4. Peer review 3.5. Funding: What is the source of funds available to conduct this project? 3.6. Conflicts of interest 3.7. Publications and Dissemination of results 4.1. Anticipated start and finish dates 4.2. Anticipated start date 4.3. Anticipated finish date SA Health LNR Application Form - Headings 5.1. 5.2. 5.3. 5.4. 5.5. 6.1. 6.2. 6.3. 6.4. Project summary Research aims and significance Research methodology Likely benefits of the project for the participants, institution and/or community Describe any potential risks associated with the project What categories or groups of participants will be involved in the project? (e.g. patients, volunteers, staff) Number of participants Inclusion and exclusion criteria (if applicable)? Describe what processes will be used to identify and recruit participants into the project (e.g. advertisements). SA Health LNR Application Form - Headings 7.1. Will informed consent be obtained from participants prior to study involvement? 8.1. Is there a requirement for the project to collect, use, or disclose individually identifiable or re-identifiable data of a personal nature 8.2. Will prior consent be gained for the use of the data specified in 8.1? 8.3. Storage and security of data Reminder… > The NHMRC National Approach to mutual recognition of ethical review applies to “clinical trials”. > There is no expectation that LNR research would similarly be covered under a mutual recognition arrangement. > Within SA Health there is an expectation that LNR research approved at one institution does not need to be rereviewed at another.